Hazard Type

Product Quality Recalls

2,865 product recalls involving product quality. Search official CPSC, FDA, and USDA datasets for every recall issued due to this hazard.

2,865Total Recalls
260Critical
322.2MUnits Affected
All Recalls

Every Product Quality Recall

Sorted by most recent. Click any recall for full details and safety information.

2,865 recalls
RecallFDA
Sun Pharmaceutical Industries Inc
Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactur...
Ophthalmic Drugs·69,707 affected·Sep 7, 2023
RecallFDA
Amerisource Health Services Llc
HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Colu...
Oral Drugs·3,344 affected·Sep 1, 2023
High RiskFDA
Vistapharm Llc
Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Manufactured and Distributed by: VistaPhar...
Oral Drugs·14,400 affected·Aug 30, 2023
High RiskFDA
Humanrace
Humanrace Suncare, Ozone Face Protection Daily Moisturizer, Broad Spectrum Sunscreen SPF 30, packaged as a 53mL (1.8 fl oz.) bottle, 100%...
Drugs·5,046 affected·Aug 18, 2023
High RiskFDA
Humanrace
Humanrace Suncare, Ozone Body Protection Cream, Broad Spectrum Sunscreen SPF 30, packaged as a 148mL (5 fl oz.) bottle, PA ++++, 100% min...
Topical Drugs·2,942 affected·Aug 18, 2023
RecallFDA
Glenmark Pharmaceuticals Inc., Usa
Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle, Rx only, Manufactured by: Glenmark Pha...
Oral Drugs·1,200 affected·Aug 14, 2023
High RiskFDA
O&m Halyard, Inc.
FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827
Respiratory Devices·41,790 affected·Aug 9, 2023
RecallFDA
Alembic Pharmaceuticals, Inc.
Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 6...
Drugs·82,400 affected·Jul 27, 2023
CriticalFDA
Hamilton Medical, Inc.
Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator
Respiratory Devices·6 affected·Jul 26, 2023
CriticalFDA
Hamilton Medical, Inc.
Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator
Respiratory Devices·76 affected·Jul 26, 2023
CriticalFDA
Hamilton Medical, Inc.
Hamilton-MR1, REF: 161010, Intensive Care Ventilator
Respiratory Devices·12 affected·Jul 26, 2023
CriticalFDA
Hamilton Medical, Inc.
Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator
Respiratory Devices·164 affected·Jul 26, 2023
CriticalFDA
Hamilton Medical, Inc.
Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator
Respiratory Devices·4 affected·Jul 26, 2023
CriticalFDA
Hamilton Medical, Inc.
Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator
Respiratory Devices·1,216 affected·Jul 26, 2023
RecallFDA
Sun Pharmaceutical Industries Inc
Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, Survey No. 259/15, ...
Oral Drugs·360 affected·Jul 18, 2023
RecallFDA
Ascend Laboratories, Llc
Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Di...
Oral Drugs·99,516 affected·Jul 18, 2023
High RiskFDA
Sun Pharmaceutical Industries Inc
Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ 08512, Manufacture...
Oral Drugs·8,880 affected·Jul 10, 2023
RecallFDA
Sun Pharmaceutical Industries Inc
Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton in a) 10 mL bottle (NDC# 62756-232-55) an...
Ophthalmic Drugs·20,884 affected·Jul 5, 2023
High RiskFDA
Accord Healthcare, Inc.
Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured ...
Injectable Drugs·1,680 affected·Jul 3, 2023
High RiskFDA
Accord Healthcare, Inc.
Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactured for: Accord Healthcare,...
Injectable Drugs·2,348 affected·Jul 3, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 8888102004HP
Surgical Devices·685 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit" REF: 8888345629
Surgical Devices·6,949 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637HP
Surgical Devices·3,965 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions REF: 8888345520HP
Surgical Devices·295 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, IC Tray REF: 8888102003HP
Surgical Devices·1,875 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit" REF: 8888345603
Surgical Devices·45,880 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629HP
Surgical Devices·7,293 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637
Surgical Devices·647 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, PASS Tray REF: 8888104003HP
Surgical Devices·1,099 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, IC Tray REF: 8888101003HP
Surgical Devices·5,373 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629
Surgical Devices·655 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637
Surgical Devices·775 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, PASS Tray REF: 8888103001HP
Surgical Devices·299 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, PASS Tray REF: 8888103002HP
Surgical Devices·299 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, PASS Tray REF: 8888104004HP
Surgical Devices·519 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions REF: 8888345512HP
Surgical Devices·600 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit" REF: 8888345611
Surgical Devices·69,987 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, IC Tray REF: 8888101002HP
Surgical Devices·6,615 affected·Jun 28, 2023
RecallFDA
Lupin Pharmaceuticals Inc.
Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21...
Oral Drugs·3,096 affected·Jun 27, 2023
CriticalFDA
Lupin Pharmaceuticals Inc.
Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets 0.451 mg...
Oral Drugs·4,179 affected·Jun 23, 2023
High RiskFDA
Amerisource Health Services Llc
Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister packs) per carton, Rx Only, Packaged and Distributed by: Am...
Oral Drugs·4,971 affected·Jun 23, 2023
High RiskFDA
Dr Reddy's Laboratories Limited
Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409 India. ND...
Oral Drugs·17,548 affected·Jun 21, 2023
RecallFDA
Avkare Llc
Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13
Oral Drugs·592 affected·Jun 13, 2023
RecallFDA
Amring Pharmaceuticals Inc
Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: Amring Pharmaceuticals Inc. Berwyn, PA 1...
Oral Drugs·48,989 affected·Jun 12, 2023
High RiskFDA
Sun Pharmaceutical Industries Inc
Amphotericin B Liposome for Injection, 50mg/vial, Rx only, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufac...
Injectable Drugs·12,960 affected·May 30, 2023
High RiskFDA
Tei Biosciences, Inc.
PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm (2:1), 20x25 cm (1:1), 4x4 cm (2:1), 6x6 cm (2:1), 8...
Medical Devices·10,159 affected·May 23, 2023
High RiskFDA
Tei Biosciences, Inc.
SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Size 10cm x 20cm
Medical Devices·9,215 affected·May 23, 2023
High RiskFDA
Tei Biosciences, Inc.
SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20...
Medical Devices·13,390 affected·May 23, 2023